A Phase 1/2, open label, first-in-human, dose escalation and expansion study for the evaluation of safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity of SAR445877 administered as monotherapy or in combination with other anticancer therapies in adults with advanced solid tumors

Conditions

Solid tumor

Brief summary

Dose escalation and Japan Cohort F: Presence of dose-limiting toxicities (DLTs) in Cycles 1 and 2, Dose escalation and Japan Cohort F: Percentage of participants experiencing treatment-emergent adverse events (TEAEs), Dose expansion/optimization: Objective response rate (ORR)

Detailed description

Dose escalation and Japan Cohort F Objective response rate (ORR), Dose escalation, expansion/optimization and Japan Cohort F Duration of response (DoR), Dose escalation, expansion/optimization and Japan Cohort F Assessment of SAR445877 Cmax, Dose escalation, expansion/optimization and Japan Cohort F Assessment of SAR445877 AUClast, Dose escalation, expansion/optimization and Japan Cohort F Assessment of SAR445877 Tmax, Part 2b Combination Assessment of Cetuximab serum concentration, Dose escalation, expansion/optimization and Japan Cohort F Percentage of participants with presence of anti-drug antibodies (ADAs) to SAR445877, Dose expansion/optimization Time to response, Dose expansion/optimization Clinical Benefit Rate, Dose expansion/optimization Progression-free survival, Dose expansion/optimization Number of participants with Adverse events (AE), Dose expansion/optimization Overall survival

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGSAR445877

DRUGErbitux 5 mg/mL solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Dose escalation and Japan Cohort F: Presence of dose-limiting toxicities (DLTs) in Cycles 1 and 2, Dose escalation and Japan Cohort F: Percentage of participants experiencing treatment-emergent adverse events (TEAEs), Dose expansion/optimization: Objective response rate (ORR)	—

Secondary

Measure	Time frame
Dose escalation and Japan Cohort F Objective response rate (ORR), Dose escalation, expansion/optimization and Japan Cohort F Duration of response (DoR), Dose escalation, expansion/optimization and Japan Cohort F Assessment of SAR445877 Cmax, Dose escalation, expansion/optimization and Japan Cohort F Assessment of SAR445877 AUClast, Dose escalation, expansion/optimization and Japan Cohort F Assessment of SAR445877 Tmax, Part 2b Combination Assessment of Cetuximab serum concentration, Dose escalation, expansion/optimization and Japan Cohort F Percentage of participants with presence of anti-drug antibodies (ADAs) to SAR445877, Dose expansion/optimization Time to response, Dose expansion/optimization Clinical Benefit Rate, Dose expansion/optimization Progression-free survival, Dose expansion/optimization Number of participants with Adverse events (AE), Dose expansion/optimization Overall survival	—

Measure

Time frame

Dose escalation and Japan Cohort F Objective response rate (ORR), Dose escalation, expansion/optimization and Japan Cohort F Duration of response (DoR), Dose escalation, expansion/optimization and Japan Cohort F Assessment of SAR445877 Cmax, Dose escalation, expansion/optimization and Japan Cohort F Assessment of SAR445877 AUClast, Dose escalation, expansion/optimization and Japan Cohort F Assessment of SAR445877 Tmax, Part 2b Combination Assessment of Cetuximab serum concentration, Dose escalation, expansion/optimization and Japan Cohort F Percentage of participants with presence of anti-drug antibodies (ADAs) to SAR445877, Dose expansion/optimization Time to response, Dose expansion/optimization Clinical Benefit Rate, Dose expansion/optimization Progression-free survival, Dose expansion/optimization Number of participants with Adverse events (AE), Dose expansion/optimization Overall survival

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Countries

Netherlands, Spain

Outcome results

None listed